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Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Quality of cardiopulmonary resuscitation (CPR) is associated with survival, but recommended guidelines are often not met, and less than half the children with an in-hospital arrest will survive to discharge. A single-center before-and-after study demonstrated that outcomes may be improved with a novel training program in which all pediatric intensive care unit staff are encouraged to participate in frequent CPR refresher training and regular, structured resuscitation debriefings focused on patient-centric physiology. METHODS/DESIGN:This ongoing trial will assess whether a program of structured debriefings and point-of-care bedside practice that emphasizes physiologic resuscitation targets improves the rate of survival to hospital discharge with favorable neurologic outcome in children receiving CPR in the intensive care unit. This study is designed as a hybrid stepped-wedge trial in which two of ten participating hospitals are randomly assigned to enroll in the intervention group and two are assigned to enroll in the control group for the duration of the trial. The remaining six hospitals enroll initially in the control group but will transition to enrolling in the intervention group at randomly assigned staggered times during the enrollment period. DISCUSSION:To our knowledge, this is the first implementation of a hybrid stepped-wedge design. It was chosen over a traditional stepped-wedge design because the resulting improvement in statistical power reduces the required enrollment by 9 months (14%). However, this design comes with additional challenges, including logistics of implementing an intervention prior to the start of enrollment. Nevertheless, if results from the single-center pilot are confirmed in this trial, it will have a profound effect on CPR training and quality improvement initiatives. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02837497 . Registered on July 19, 2016.

SUBMITTER: Reeder RW

PROVIDER: S-EPMC5883604 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial.

Reeder Ron W RW Girling Alan A Wolfe Heather H Holubkov Richard R Berg Robert A RA Naim Maryam Y MY Meert Kathleen L KL Tilford Bradley B Carcillo Joseph A JA Hamilton Melinda M Bochkoris Matthew M Hall Mark M Maa Tensing T Yates Andrew R AR Sapru Anil A Kelly Robert R Federman Myke M Michael Dean J J McQuillen Patrick S PS Franzon Deborah D Pollack Murray M MM Siems Ashley A Diddle John J Wessel David L DL Mourani Peter M PM Zebuhr Carleen C Bishop Robert R Friess Stuart S Burns Candice C Viteri Shirley S Hehir David A DA Whitney Coleman R R Jenkins Tammara L TL Notterman Daniel A DA Tamburro Robert F RF Sutton Robert M RM

Trials 20180403 1

<h4>Background</h4>Quality of cardiopulmonary resuscitation (CPR) is associated with survival, but recommended guidelines are often not met, and less than half the children with an in-hospital arrest will survive to discharge. A single-center before-and-after study demonstrated that outcomes may be improved with a novel training program in which all pediatric intensive care unit staff are encouraged to participate in frequent CPR refresher training and regular, structured resuscitation debriefin ...[more]

PMID: 29615134

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Project description:OBJECTIVES:In-hospital cardiac arrest occurs in 2.6-6% of children with cardiac disease and is associated with significant morbidity and mortality. Much remains unknown about cardiac arrest in pediatric cardiac ICUs; therefore, we aimed to describe cardiac arrest epidemiology in a contemporary multicenter cardiac ICU cohort. DESIGN:Retrospective analysis within the Pediatric Cardiac Critical Care Consortium clinical registry. SETTING:Cardiac ICUs within 23 North American hospitals. PATIENTS:All cardiac medical and surgical patients admitted from August 2014 to July 2016. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:There were 15,908 cardiac ICU encounters (6,498 medical, 9,410 surgical). 3.1% had cardiac arrest; rate was 4.8 cardiac arrest per 1,000 cardiac ICU days. Medical encounters had 50% higher rate of cardiac arrest compared with surgical encounters. Observed (unadjusted) cardiac ICU cardiac arrest prevalence varied from 1% to 5.5% among the 23 centers; cardiac arrest per 1,000 cardiac ICU days varied from 1.1 to 10.4. Over half cardiac arrest occur within 48 hours of admission. On multivariable analysis, prematurity, neonatal age, any Society of Thoracic Surgeons preoperative risk factor, and Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery mortality category 4, 5 had strongest association with surgical encounter cardiac arrest. In medical encounters, independent cardiac arrest risk factors were acute heart failure, prematurity, lactic acidosis greater than 3 mmol/dL, and invasive ventilation 1 hour after admission. Median cardiopulmonary resuscitation duration was 10 minutes, return of spontaneous circulation occurred in 64.5%, extracorporeal cardiopulmonary resuscitation in 27.2%. Unadjusted survival was 53.2% in encounters with cardiac arrest versus 98.2% without. Medical encounters had lower survival after cardiac arrest (37.7%) versus surgical encounters (62.5%); Norwood patients had less than half the survival after cardiac arrest (35.6%) compared with all others. Unadjusted survival after cardiac arrest varied greatly among 23 centers. CONCLUSIONS:We provide contemporary epidemiologic and outcome data for cardiac arrest occurring in the cardiac ICU from a multicenter clinical registry. As detailed above, we highlight high-risk patient cohorts and periods of time that may serve as targets for research and quality improvement initiatives aimed at cardiac arrest prevention.

Project description:The modern treatment of cardiac arrest is an increasingly complex medical procedure with a rapidly changing array of therapeutic approaches designed to restore life to victims of sudden death. The 2 primary goals of providing artificial circulation and defibrillation to halt ventricular fibrillation remain of paramount importance for saving lives. They have undergone significant improvements in technology and dissemination into the community subsequent to their establishment 60 years ago. The evolution of artificial circulation includes efforts to optimize manual cardiopulmonary resuscitation, external mechanical cardiopulmonary resuscitation devices designed to augment circulation, and may soon advance further into the rapid deployment of specially designed internal emergency cardiopulmonary bypass devices. The development of defibrillation technologies has progressed from bulky internal defibrillators paddles applied directly to the heart, to manually controlled external defibrillators, to automatic external defibrillators that can now be obtained over-the-counter for widespread use in the community or home. But the modern treatment of cardiac arrest now involves more than merely providing circulation and defibrillation. As suggested by a 3-phase model of treatment, newer approaches targeting patients who have had a more prolonged cardiac arrest include treatment of the metabolic phase of cardiac arrest with therapeutic hypothermia, agents to treat or prevent reperfusion injury, new strategies specifically focused on pulseless electric activity, which is the presenting rhythm in at least one third of cardiac arrests, and aggressive post resuscitation care. There are discoveries at the cellular and molecular level about ischemia and reperfusion pathobiology that may be translated into future new therapies. On the near horizon is the combination of advanced cardiopulmonary bypass plus a cocktail of multiple agents targeted at restoration of normal metabolism and prevention of reperfusion injury, as this holds the promise of restoring life to many patients for whom our current therapies fail.

Project description:Background and objectivesPatients on maintenance dialysis with in-hospital cardiac arrest have been reported to have worse outcomes relative to those not on dialysis; however, it is unknown if poor outcomes are related to the quality of resuscitation. Using the Get With The Guidelines-Resuscitation (GWTG-R) registry, we examined processes of care and outcomes of in-hospital cardiac arrest for patients on maintenance dialysis compared with nondialysis patients.Design, setting, participants, & measurementsWe used GWTG-R data linked to Centers for Medicare and Medicaid data to identify patients with ESKD receiving maintenance dialysis from 2000 to 2012. We then case-matched adult patients on maintenance dialysis to nondialysis patients in a 1:3 ratio on the basis of age, sex, race, hospital, and year of arrest. Logistic regression models with generalized estimating equations were used to assess the association of in-hospital cardiac arrest and outcomes by dialysis status.ResultsAfter matching, there were a total of 31,144 GWTG-R patients from 372 sites, of which 8498 (27%) were on maintenance dialysis. Patients on maintenance dialysis were less likely to have a shockable initial rhythm (20% versus 21%) and less likely to be within the intensive care unit at the time of arrest (46% versus 47%) compared with nondialysis patients; they also had lower composite scores for resuscitation quality (89% versus 90%) and were less likely to have defibrillation within 2 minutes (54% versus 58%). After adjustment, patients on maintenance dialysis had similar adjusted odds of survival to discharge (odds ratio [OR], 1.05; 95% confidence interval [95% CI], 0.97 to 1.13), better acute survival (OR, 1.33; 95% CI, 1.26 to 1.40), and were more likely to have favorable neurologic status (OR, 1.12; 95% CI, 1.04 to 1.22) compared with nondialysis patients.ConclusionsAlthough there appears to be opportunities to improve the quality of in-hospital cardiac arrest care for among those on maintenance dialysis, survival to discharge was similar for these patients compared with nondialysis patients.

Project description:BackgroundMaternal in-hospital cardiac arrest is a rare event with the potential for resuscitation treatment delays because of the difficulty accessing hospital obstetrical units and limited simulation training or resuscitation experience of obstetrical staff. However, it is unclear whether survival rates and processes of care differ between women with a maternal in-hospital cardiac arrest and those with a nonmaternal in-hospital cardiac arrest.ObjectiveWe aimed determine whether to there are delays in process measures and differences in survival outcomes between pregnant and nonpregnant women who have in-hospital cardiac arrest.Study designUsing data from 2000 to 2019 in the Get With The Guidelines-Resuscitation registry, we compared resuscitation outcomes between women aged 18 to 50 years with a maternal or nonmaternal in-hospital cardiac arrest. Using a nonparsimonious propensity score, we matched patients with a maternal in-hospital cardiac arrest to as many as 10 women with a nonmaternal in-hospital cardiac arrest. We constructed conditional logistic regression models to compare survival outcomes (survival to discharge, favorable neurologic survival [discharge cerebral performance score of 1], and return of spontaneous circulation) and processes of care (delayed defibrillation [>2 minutes] and administration of epinephrine [>5 minutes]) between women with a maternal in-hospital cardiac arrest vs those with a nonmaternal in-hospital cardiac arrest.ResultsOverall, 421 women with a maternal in-hospital cardiac arrest were matched by propensity score to 2316 women with a nonmaternal in-hospital cardiac arrest. The mean age among propensity score-matched women with a maternal in-hospital cardiac arrest was 31.4 (standard deviation, 6.5) years, where 33.7% were of Black race and 86.9% had an initial nonshockable cardiac arrest rhythm. Unadjusted survival rates were higher in women with a maternal in-hospital cardiac arrest than in women with a nonmaternal in-hospital cardiac arrest: survival to discharge of 45.1% vs 26.5%, survival with cerebral performance category 1 status of 36.1% vs 17.7%, and return of spontaneous circulation of 75.8% vs 70.6%. After adjustment, there was no difference in the likelihood of survival to discharge (odds ratio, 1.19; 95% confidence interval, 0.82-1.73) or return of spontaneous circulation (odds ratio, 0.94; 95% confidence interval, 0.65-1.35) between women with a maternal in-hospital cardiac arrest and those with a nonmaternal in-hospital cardiac arrest. However, women with a maternal in-hospital cardiac arrest were more likely to have favorable neurologic survival (odds ratio, 1.57; 95% confidence interval, 1.06-2.33). Compared with women with a nonmaternal in-hospital cardiac arrest, women with a maternal in-hospital cardiac arrest had similar rates of delayed defibrillation (42.5% vs 34.4%; odds ratio, 1.14 [95% confidence interval, 0.41-3.18]; P=.31) and delayed administration of epinephrine (13.8% vs 10.6%; odds ratio, 0.96 [95% confidence interval, 0.50-1.86]; P=.09).ConclusionAlthough concerns have been raised about resuscitation outcomes in women with a maternal in-hospital cardiac arrest, the rates of survival and resuscitation processes of care were not worse in women with a maternal in-hospital cardiac arrest.

Project description:ImportanceMortality from pediatric out-of-hospital cardiac arrest (OHCA) is high and has not improved in decades, unlike adult mortality. The low frequency of pediatric OHCA and weight-based medication and equipment needs may lead to lower quality of pediatric resuscitation compared with adults.ObjectiveTo compare the quality of pediatric and adult resuscitation from OHCA in a controlled simulation environment and to evaluate whether teamwork, knowledge, experience, and cognitive load are associated with resuscitation performance.Design, setting, and participantsThis cross-sectional in-situ simulation study was conducted between September 2020 and August 2021 in the metropolitan area of Portland, Oregon, and included engine companies from fire-based emergency services (EMS) agencies.ExposuresParticipating EMS crews completed 4 simulation scenarios presented in random order: (1) adult female with ventricular fibrillation; (2) adult female with pulseless electrical activity; (3) school-aged child with ventricular fibrillation; and (4) infant with pulseless electrical activity. All patients were pulseless on EMS arrival. Data were captured by the research team in real time during the scenarios.Main outcomes and measuresThe primary outcome was defect-free care, which included correct cardiopulmonary resuscitation depth, rate, and compression to ventilation ratio, time to bag-mask ventilation, and time to defibrillation, if applicable. Outcomes were determined by direct observation by an experienced physician. Secondary outcomes included additional time-based interventions and the use of correct medication doses and equipment size. We measured teamwork using the clinical teamwork scale, cognitive load with the National Aeronautics and Space Administration task load index (NASA-TLX), and knowledge using advanced life support resuscitation tests.ResultsAmong the 215 clinicians (39 crews) who participated in 156 simulations, 200 (93%) were male, and the mean (SD) age was 38.7 (0.6) years. No pediatric shockable scenario was defect free and only 5 pediatric nonshockable scenarios (12.8%) were defect free, while 11 (28.2%) adult shockable scenarios and 27 adult nonshockable scenarios (69.2%) were defect free. The mental demand subscale of the NASA-TLX was higher in the pediatric compared with the adult scenarios (mean [SD] pediatric score, 59.1 [20.7]; mean [SD] adult score, 51.4 [21.1]; P = .01). Teamwork scores were not associated with defect-free care.Conclusions and relevanceIn this simulation study of OHCA, resuscitation quality was significantly lower for pediatric than adult resuscitation. Mental demand may have been a contributor.

Project description:BACKGROUND:Delirium affects nearly 70% of older adults hospitalized in the intensive care unit (ICU), and many of those will be left with persistent cognitive impairment or dementia. There are no effective and scalable recovery models to remediate ICU-acquired cognitive impairment and its attendant elevated risk for dementia or Alzheimer disease (AD). The Improving Recovery and Outcomes Every Day after the ICU (IMPROVE) trial is an ongoing clinical trial which evaluates the efficacy of a combined physical exercise and cognitive training on cognitive function among ICU survivors 50 years and older who experienced delirium during an ICU stay. This article describes the study protocol for IMPROVE. METHODS:IMPROVE is a four-arm, randomized controlled trial. Subjects will be randomized to one of four arms: cognitive training and physical exercise; cognitive control and physical exercise; cognitive training and physical exercise control; and cognitive control and physical exercise control. Facilitators administer the physical exercise and exercise control interventions in individual and small group formats by using Internet-enabled videoconference. Cognitive training and control interventions are also facilitator led using Posit Science, Inc. online modules delivered in individual and small group format directly into the participants' homes. Subjects complete cognitive assessment, mood questionnaires, physical performance batteries, and quality of life scales at baseline, 3, and 6 months. Blood samples will also be taken at baseline and 3 months to measure pro-inflammatory cytokines and acute-phase reactants; neurotrophic factors; and markers of glial dysfunction and astrocyte activation. DISCUSSION:This study is the first clinical trial to examine the efficacy of combined physical and cognitive exercise on cognitive function in older ICU survivors with delirium. The results will provide information about potential synergistic effects of a combined intervention on a range of outcomes and mechanisms of action. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03095417 . Registered on 23 March 2017. Last updated on 15 May 2017.

Dataset Information

Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial.

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Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial.

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